The present invention relates to a device, system and method suitable for positioning and optionally anchoring devices with a lumen or passageway of a body.
Various treatment approaches require positioning of devices in body lumens or passageways. For example, devices positioned within the lumen of the gastrointestinal (GI) tract are utilized in a variety of gastrointestinal procedures, such as stomach volume reduction, placement of stomach-anchored devices such as electrodes and sphincter repair [e.g. gastro esophageal reflux disorder (GERD) treatment]. Such devices are typically anchored to tissues surrounding/forming the passageway or lumen to ensure accurate positioning of the device.
Current devices are limited by the strength of anchoring and are further hampered by complicated and clinically invasive anchoring procedures. Most currently utilized anchors utilize a soft or hard tissue anchoring element for penetrating and anchoring to a tissue encompassing the passageway or lumen and a short length of suture which is attached to a device body. Although such anchor configurations are designed to have some compliance under pull forces by virtue of the suturing path, the inelastic nature of the suture portion of the anchor oftentimes leads to tissue tearing, erosion, infections, device migration, and anchor dislodgement. In the GI tract with intense peristalsis, in-tissue anchor elements are exposed to significant mechanical forces and a harsh chemical environment, making long term anchoring very difficult with presently available anchor designs.
Although a variety of anchor designs attempt to solve these problems, very few approaches manage to achieve adequate long lasting fixation of devices to soft tissue of the GI tract. In addition, positioning a device body within a lumen (e.g. stomach lumen) and anchoring it via a tether to tissue surrounding the lumen (e.g. stomach wall) requires complicated open, laparoscopic or endoscopic procedures.
While reducing the present invention to practice the present inventors have devised a novel anchoring scheme which traverses the limitations of presently described anchoring approaches and provides long lasting and easily deployable anchoring of devices in a lumen or passageway of the body.